HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed) | RFA HL 19 028

Opportunity Information: Apply for RFA HL 19 028

The NIH funding opportunity RFA-HL-19-028, titled "HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT)" supports R01 research projects that focus on how sleep and circadian biology shape opioid addiction risk, withdrawal biology, and responses to medication-assisted treatment. The central goal is to push basic and translational understanding of the underlying mechanisms linking sleep and circadian systems to OUD, rather than simply describing associations. In practical terms, NIH is looking for studies that can clarify how disruptions in sleep or circadian timing might contribute to developing OUD, how opioid exposure and withdrawal may in turn disrupt sleep and circadian function, and how those bidirectional effects could influence treatment response and recovery outcomes when medications like MAT are used.

A major emphasis of the announcement is directionality and mechanism. Applicants are expected to move beyond correlation and address questions such as whether sleep or circadian disruption increases vulnerability to OUD, whether OUD-related neuroadaptations produce sleep and circadian pathology that worsens withdrawal or relapse risk, and which neurobiological pathways are responsible for these interactions. The FOA highlights the need to apply modern advances in sleep and circadian neurobiology to opioid-use-related questions, with an eye toward identifying actionable targets that could improve therapy and outcomes. While the topic is clinically relevant, the mechanism-focused framing signals strong interest in foundational biology that can explain why sleep and circadian factors matter for opioid use, withdrawal severity, and treatment effectiveness.

The FOA strongly encourages multidisciplinary, team-based applications. Competitive projects are expected to bring together investigators with complementary expertise, specifically combining sleep and circadian neurobiology with the neurobiology of OUD and the pharmacology of medication-assisted treatment. This team science orientation reflects the complexity of the problem: integrating neural circuit mechanisms, molecular and cellular pathways, pharmacologic effects of MAT, and measurable sleep/circadian phenotypes to build coherent mechanistic models that can ultimately inform better interventions.

The scope is intentionally narrow regarding substances studied. The FOA is only responsive to research focused on OUD-relevant mechanisms and pathobiology. Studies centered on other drugs of abuse are explicitly non-responsive, meaning an application that primarily examines non-opioid substances (even if sleep and circadian issues are involved) would not fit this announcement. The funding mechanism is an R01, and the opportunity is designated "Clinical Trial Not Allowed," which generally means applicants should not propose prospective studies in which human participants are assigned to interventions to evaluate health-related outcomes. Applicants can still often include human-oriented mechanistic work if it does not meet the NIH definition of a clinical trial, but the intent here is to keep the portfolio focused on mechanistic research rather than interventional trials.

From an administrative standpoint, this is a discretionary NIH grant opportunity under health-related CFDA program areas (93.233, 93.279, 93.837, 93.838, 93.839). The opportunity lists an award ceiling of $350,000 (as provided in the source data) and had an original closing date of February 27, 2019, with a creation date of December 10, 2018. While the closing date indicates this specific FOA is historical, the summary still captures what NIH was soliciting under this announcement and can be useful as a guide to the kind of research themes NIH has prioritized under the HEAL Initiative.

Eligibility is broad across U.S.-based organizations and includes many government and non-government applicant types. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, eligible federal government agencies, and Indian/Native American tribal governments other than federally recognized.

At the same time, the FOA clearly restricts foreign involvement. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible, and foreign components (as defined by NIH Grants Policy) are not allowed. In other words, the work and organizational footprint supported by this FOA must remain domestic, with no foreign components built into the proposed project structure.

Overall, this opportunity targets mechanistic, opioid-specific research at the intersection of sleep/circadian biology and OUD, including withdrawal and MAT response, with a clear preference for integrative, cross-disciplinary teams and a firm exclusion of clinical trials and non-opioid substance-focused studies. The intended payoff is a sharper, mechanistically grounded understanding of how sleep and circadian systems influence opioid addiction trajectories and treatment response, creating a foundation for improved therapeutic strategies and better recovery outcomes in the future.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.279, 93.837, 93.838, 93.839.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-02-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $350,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HL 19 028

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